BlueCross BlueShield of Tennessee Medical Policy Manual

Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty

DESCRIPTION

Percutaneous vertebral augmentation (e.g. vertebroplasty, kyphoplasty, sacroplasty) encompasses a variety of minimally invasive procedures for treating vertebral compression fractures (VCF). Clinical symptoms associated with VCFs include: back pain, limited spinal mobility, height loss, and/or deformity and disability. Compression fractures are diagnosed using a combination of medical history and physical examination and may be confirmed using imaging techniques. On x-ray a wedge-shaped vertebra may be visible or there may be loss of height of the vertebra. The weakened bone compresses, or collapses in on itself; a fracture may occur while one is bending, twisting, or a fall from standing height or less. Only about one-third of vertebral compression fractures reach clinical diagnosis, with most symptomatic fractures healing within a few weeks. Medical management, including nonsteroidal anti-inflammatory drugs, oral analgesics, bracing and physical therapy remains the first-line therapy for individuals with a vertebral compression fracture. If medical management is unsuccessful or unfeasible surgical management can include:

Vertebroplasty - performed by percutaneous injection of radiopaque bone cement, usually polymethyl-methacrylate (PMMA) (e.g.,Spine-Fix® Biomimetic Bone Cement, Osteopal® V) into a painful osteoporotic or neoplastic compression fracture. Percutaneous vertebroplasty has also been used as to treat osteolytic vertebral metastasis or myeloma, and as an adjunct to surgery for aggressive vertebral body hemangiomas, as a technique to limit blood loss related to surgery. The technique has been used in all levels of the vertebrae (i.e., cervical, thoracic, and lumbar).

Kyphoplasty - a variant of vertebroplasty and has traditionally been done by inflation of a balloon (e.g., Kyphoon®) in the fractured vertebral body to restore vertebral height before the balloon is removed and cement injected. Newer techniques also known as mechanical vertebral augmentation include implantation of a continuous loop-like spinal device (i.e., Kiva® VCF Treatment System) through which the cement is injected with the device remaining in place. 

Radiofrequency targeted vertebral augmentation - a modified technique being investigated to treat vertebral compression fractures where a motorized cement delivery system in vertebroplasty or kyphoplasty allows for radiofrequency warming of high viscosity cement during delivery. The high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture. However, thermal damage to intraosseous nerve fibers is a concern.

Sacroplasty - is being investigated as a technique to provide stabilization to the sacral area. Percutaneous sacroplasty involves the injection of PMMA into sacral insufficiency fractures (SIFs) for stabilization. It has been proposed that this procedure may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body.

These procedures require fluoroscopic or ultrasound guidance. With any type of vertebral augmentation, there is risk of the bone cement migrating out of place (called extravasation). In some cases this has led to transient radicular pain, neurologic symptoms, pulmonary embolism, deep vein thrombosis, and/or pneumonia. Evidence also suggests there may be an increased rate of subsequent fractures in adjacent vertebrae.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

There is a lack of randomized controlled trials on percutaneous sacroplasty for sacral insufficiency. The small numbers of treated individuals in cohort studies and retrospective reviews leave uncertainty regarding the impact of sacroplasty on health outcomes. Devices for kyphoplasty, other than the Kiva® VCS Treatment System, have few or no high quality clinical studies to demonstrate safety and/or effectiveness.

SOURCES

American Academy of Orthopaedic Surgeons. (2010). The treatment of symptomatic osteoporotic spinal compression fractures guideline and evidence report. Retrieved August 7, 2012 from http://www.aaos.org.

American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Society of Interventional Radiology (SIR), and Society of NeuroInterventional Surgery (SNIS). (2017) Practice parameter for the performance of vertebral augmentation (Resolution 16, Revised 2017). Retrieved August 21, 2017 from: http://www.acr.org/guidelines.

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved August 21, 2017 from BlueWeb. (43 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation. (6.01.38). Retrieved August 21, 2017 from BlueWeb. (29 articles and/or guidelines reviewed)

Bouza, C., Lopez-Cuadrado, T., Cediel, P., Saz-Parkinson, Z., & Amate, J. M. (2009). Balloon kyphoplasty in malignant spinal fractures: a systematic review and meta-analysis. BMC Palliative Care, 8, 12. (Level 1 evidence)

Buchbinder, R., Golmohammadi, K., Johnston, R., Owen, R., Homik, J., Jones, A., et al. (2015, April) Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.Cochrane Database Systems Review, (4), CD006349. Abstract retrieved August 31, 2017 from PubMed database.

Buchbinder, R., Osborne, R. H., Ebeling, P. R., Wark, J. D., Mitchell, P., Wriedt, C., et al. (2009). A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. New England Journal of Medicine, 361 (6), 557-568. (Level 2 evidence - Independent)

Cahaba Government Benefit Administrators, LLC. (2017, February) Local Coverage Determination (LCD): Surgery: Vertebral Augmentation Procedures (VAPs) (L34300) Retrieved August 21, 20017 from https://www.cms.gov.

Denaro, L., Longo, U. G., & Denaro, V. (2009). Vertebroplasty and kyphoplasty: Reasons for concern? The Orthopedic Clinics of North America, 40 (4), 465-471. (Level 5 evidence)

Fan, J., Shen, Y., Zhan, N.,  Ren, Y., Cai, W., Yu, L. et al. (2016) Evaluation of surgical outcome of Jack vertebral dilator kyphoplasty for osteoporotic vertebral compression fracture-clinical experience of 218 cases. Journal of Orthopedic Surgery and Research, 11 (56). (Level 4 evidence)

Feng, L., Shen, J., Feng, C., Chen, C., and Wu, Y. (2017, April). Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fractures. Medicine, 96 (25). (Level 2 evidence)

Hsieh, M., Chen, L., & Chen, W. (2013). Current concepts of percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: evidence-based review. Biomedical Journal, 36 (4), 154-161. (Level 1 evidence)

Jones, J. O., Bruel, B. M., & Vattam, S. R. (2009). Management of painful vertebral hemangiomas with kyphoplasty: A report of two cases and a literature review. Pain Physician, 12 (4), E297-E303. (Level 4 evidence - Independent study)

Kallmes, D. V., Comstock, B. A., Heagerty, P. J., Turner, J. A., Wilson, D. J., Diamond, et al. (2009). A randomized trial of vertebroplasty for osteoporotic spinal fractures (INVEST). New England Journal of Medicine, 360 (6), 569-579. (Level 2 evidence- Industry supported)

Korovessis, P., Vardakastanis, K., Repantis, T., and Vitsas, V. (2013, February) Balloon kyphoplasty versus KIVA vertebral augmentation-- comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine, 38 (4), 292-9. Abstract retrieved August 31, 2017 from PubMed database.

Liang, L., Chen, X., Jiang, W., Li, W., Chen, J., Wu, L., et al. (2016). Balloon kyphoplasty or percutaneous vertebroplasty for osteoporotic vertebral compression fracture? An updated systematic review and meta-analysis. Annals of Saudi Medicine, 36 (3), 165-174. (Level 1 evidence)

Mattie, R., Laimi, K., Yu, S., & Saltychev, M. (2016). Comparing percutaneous vertebroplasty and conservative therapy for treating osteoporotic compression fractures in the thoracic and lumbar spine: A systematic review and meta-analysis. The Journal of Bone and Joint Surgery-American, 98 (12), 1041-1051. Abstract retrieved September 13, 2016 from PubMed database. (Level 1 evidence)

National Institute for Health Research. Health Technology Assessment. (2014). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis. Retrieved April 4, 2014 from http://www.journalslibrary.nihr.ac.uk.

National Institute of Health and Clinical Excellence. (2006). Balloon kyphoplasty for vertebral compression fractures, interventional procedures guidance. Retrieved August 21, 2017 from www.nice.org.uk.

National Institute of Health and Clinical Excellence. (2013). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. Technology appraisal guidance. Retrieved August 21, 2017 from www.nice.org.uk.

Noriega, D., Maestretti, G., Renaud, C. Francaviglia, N., Ould-Slimane, M., Queinnec, S. et al. (2015) Clinical performance and safety of 108 SpineJack implantations: 1-year results of a prospective multicentre single-arm registry study. BioMed Research International, article ID: 173872. (Level 4 evidence)

Olivarez, L., Dipp, J., Escamilla, R., Bajares, G., Perez, A., Stubbs, H., et al. (2011) Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS Journal 5 (2011) 114-119. (Level 4 evidence)

Pflugmacher, R., Bornemann, R., Koch, E., Randau, T., Müller-Broich, J., Lehmann, U., et al. (2012, February) Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty. Z. Orthop. Unfall., 150 (1), 56-61. Abstract retrieved August 31, 2017 from PubMed database.

Rodriguez, A., Fink, H., Mirigian, L., Guañabens, N., Eastell, R., Akesson, K., et al. (2017, September) Pain, quality of life, and safety outcomes of kyphoplasty for vertebral compression fractures: report of a task force of the american society for bone and mineral research. Journal of Bone & Mineral Research, 32 (9), 1935-44. Abstract retrieved September 1, 2017 from PubMed database.

Tutton, S., Pflugmacher, R., Davidian, M., Beall, D., Facchini, F., and Garfin, S. (2015, June) KAST Study: The Kiva System as a vertebral augmentation treatment-s safety and effectiveness trial: a randomized, noninferiority trial comparing the Kiva system with balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine, 15 (12), 865-75. Abstract retrieved September 1, 2017 from PubMed database.

U. S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053336 (StaXx™ FX System). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2007, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070015 (PMMA). Retrieved October 13, 2009 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2009, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090986 (StabiliT ER™ RFA Bone Cement Dispenser). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093477 (Kyphoon®). Retrieved August 7, 2012 from http://www.accessdata.fda.gov. 

U. S. Food and Drug Administration. (2013 April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130402 (Spider System). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K132817 (Kiva®). Retrieved April 21. 2014 from http://www.accessdata.fda.gov.

Van Meirhaeghe, J., Bastian, L., Boonen, S., Ranstam, J., Tillman, J., Wardlaw, D. (2013). A randomized trial of balloon kyphoplasty and nonsurgical management for the treatment of acute vertebral compression fractures. Spine, 38 (12), 971-983. (Level 2 evidence - Industry supported)

Vanni, D.,  Pantalone, A.,  Bigossi, F., Pineto, F., Lucantoni, D., and Salini V. (2012) New perspective for third generation percutaneous vertebral augmentation procedures: preliminary results at 12 months. Journal of Craniovertebral Junction & Spine, 3 (2), 47-51. (Level 2 evidence)

Wallace, A., Tomasian, A., Vaswani, R., Chang, R., and Jennings, J. (2016, April) Radiographic local control of spinal metastases with percutaneous radiofrequency ablation and vertebral augmentation. American Journal of Neuroradiology, 37, 579-565. (Level 4 evidence)

Wang, H., Sribastav, S., Ye, F., Yang, C., Wang, J., Liu, H., et al. (2015). Comparison of percutaneous vertebroplasty and balloon kyphoplasty for the treatment of single level vertebral compression fractures: A meta-analysis of the literature. Pain Physician, 18 (3), 209-222. Abstract retrieved September 13, 2016 from PubMed database. (Level 1 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, March). Percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Retrieved August 21, 2017 from www.Hayesinc.com  (55 articles and/or guidelines reviewed)

Yi, H. J., Jeong, J. H., Im, S. B., & Lee, J. K. (2016). Percutaneous vertebroplasty versus conservative treatment for one level thoracolumbar osteoporotic compression fracture: Results of an over 2-year follow-up. Pain Physician, 19 (5), 743-750.

Yu, C., Hsieh, M., Chen, L., Niu, C., Fu, T., Lai, P., et al. (2014), Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures. BMC Surgery, 14 (3), (Level 3 evidence - Independent)

ORIGINAL EFFECTIVE DATE:  4/1/2001

MOST RECENT REVIEW DATE:  12/20/2017

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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